The Cellular Products Laboratory (CPL) is dedicated to generation and preparation of quality products for tumor vaccines and for cellular and gene therapy of cancer. This laboratory has assumed an increasingly important role in supporting the conduct of novel immunotherapy clinical trials and gene therapy clinical trials at the UPCI. It performs 3,464 procedures annually and these vary in complexity from large-scale cell production to smaller cultures for research and development purposes. The main users are members of the Biological Therapeutics Program and the Head and Neck Cancer Program. In FY 2002, the CPL services were utilized to support 14 clinical or research protocols. Its responsibilities include cell culture of hematopoietic or non-hematopoietic cells, vaccine preparation, genetic modification of human cells, tissue procurement, processing and distribution for clinical trials, sterility and safety evaluation of each product prior to its administration to patients, and development of new products and procedures for use in future clinical protocols. The CPL pilots preparation of new cellular products, and assists in preparation of INDs. Once IRB and FDA approvals are obtained, the CPL produces and delivers to the bedside therapeutic-grade cells. Recently, generation of dendritic cell (DC)-based vaccines and research associated with therapeutic DC generation have been the major effort, representing nearly 80% of CPL activities. The CPL is operated according to FDA criteria for good manufacturing practice (GMP). The CPL has established a fee-for-service price schedule. The Laboratory has established an excellent record of accomplishments and its unique expertise has enabled rapid translation of novel technologies to clinical trials.